BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS ECHARGER

    MDR report key: 3766063 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00028
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED LATE BECAUSE THE INCIDENT WAS INCORRECTLY CLASSIFIED AS NOT MDR REPORTABLE. A RETROSPECTIVE REVIEW OF COMPLAINTS, HOWEVER IDENTIFIED THIS INCIDENT AS MDR REPORTABLE. INVESTIGATION AND CONCLUSION: INVESTIGATION DETERMINED THE POWER SUPPLY FAILED THE SPECIFICATION. THE FAILURE WAS REPRODUCIBLE. THE ROOT CAUSE WAS DEFECTIVE MINI-USB-PLUG OF GLOBTEK POWER SUPPLY. GLOBTEK DETERMINED THAT THE FAILURE WAS USER ERROR. THE CORRECTIVE ACTION WAS TO CHANGE TO KUANTECH POWER SUPPLIES. THE EUROPEAN POWER SUPPLY ADAPTER IS NOT USED IN THE U.S.

    Description of Event or Problem · 1

    (B)(6) INCIDENT WHERE THE EUROPEAN POWER ADAPTER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667300 SIEMENS ECHARGER HEARIGN AID CHARGER ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1